Orizuru Therapeutics, Inc. (OZTx), a Japanese biotechnology company focusing on the research and development of iPSC-derived regenerative medicine, and PeptiGrowth Inc. (PeptiGrowth), a Japanese biotechnology company specializing in the development of synthetic peptide based growth factors, are pleased to announce the successful completion of the joint development project (first announced on August 23, 2023) for chemically synthesized peptide as an alternative to specific recombinant growth factors used in the manufacturing of regenerative medicine products developed by OZTx. The developed peptide was confirmed to bind to cellular receptors in a manner similar to the respective recombinant growth factor, inducing phosphorylation and signaling within the cells, thereby triggering differentiation and proliferation of iPSCs. [Read more…]
Eterna Therapeutics Releases Positive Preclinical Results for ERNA-101, an Allogenic iMSC Therapeutic
ERNA-101 is a cell therapy that utilizes iPSCs to create induced allogenic mesenchymal stem cells (iMSCs) that secrete interleukins IL-7 and IL-15.
Proof-of-concept study provides roadmap for treatment of ovarian cancer.
CAMBRIDGE, Mass., Jan. 14, 2025 — Eterna Therapeutics (Nasdaq: ERNA), a leader in cell therapies for the treatment of advanced solid tumors, announced positive results from a preclinical study on the company’s lead cell therapy product, ERNA-101, which is designed to activate and regulate the immune system’s response to recognize and attack ovarian cancer cells. This successful proof-of-concept study demonstrated massive T cell infiltration after only one dose of ERNA-101, reduced tumor burden, and extended survival in mice with ovarian cancer. [Read more…]
CHU Toulouse receives CTA Approval to initiate ALLOFIST, a Phase 1/2 Trial based on Cell-Easy’s proprietary adipose-derived MSC in Patients suffering from Crohn Disease.
Toulouse, France, January 16, 2025 – The long-term partnership between Cell-Easy and Toulouse University Hospital (CHU Toulouse) continues to bear fruits, bringing innovative MSC-based therapies to local patient cohorts. This time, it’s in the field of Crohn’s disease that the pair is experimenting with the allogeneic cell therapy approach. By tackling all CMC, regulatory and medico-economic concerns, the Cell-Easy CDMO has succeeded in developing a cell therapy drug from scratch in just 2 years. The principal investigator Dr Etienne Buscail, a colo-rectal surgeon and proctologist at Toulouse University Hospital, recently submitted a request for authorization of CTA to the European Agency EMA, which was rapidly accepted. An initial cohort of patients suffering from Crohn’s disease will be able to benefit from this experimental innovant treatment starting in 2025 Q1. [Read more…]
Nucleus Biologics Becomes First Custom Cell Culture Media Company to Achieve EXCiPACT Certification for the Manufacture of Excipient GMP Quality Cell Culture Media, Supplements, and Buffers
San Diego, CA, January 9, 2025 – Nucleus Biologics, a leader in precision cell culture media development, is proud to announce that it has achieved an industry-leading quality milestone. It has received EXCiPACT certification for Pharmaceutical Excipients and Pharmaceutical Auxiliary Materials (PAMs) and ISO 9001 certification from SGS. This Excipient GMP certification will better support the cell culture media, buffers, reagents, and supplements needs for our cell and gene therapy customers. This certification, in addition to our ISO 13485 certification, underscores Nucleus Biologics’ commitment to delivering the highest quality products that meet the most stringent safety, consistency, and compliance requirements of the biopharmaceutical industry. [Read more…]
I Peace manufactures 100 lines of GMP iPS Cells cumulatively
Proof of customer recognition of its quality and mass manufacturing capability
Palo Alto, CA, January 7, 2025 — Leading GMP cell CDMO I Peace, Inc., specializing in induced pluripotent stem cells (iPSCs) and iPSC-derived cell therapies, announced that the number of GMP-grade iPS cells manufactured has reached 100 lines. This achievement solidifies I Peace as a true leader in the realm of iPS cell manufacturers, equipped with abundant experience in manufacturing GMP-grade iPS cells in compliance with global regulations. [Read more…]
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